FDA Medical Device Recalls (openFDA)
Biomet 3i, LLC: Certain Low-Profile, Angled Abutment, Model Number ILPAC3217. Product is labeled in part: "***Biomet 3i***4555 Riverside Drive , Palm Beach Gardens, FL 33410 USA***REF ILPAC3217***LOT 2011091179***Certain Low Profile 17 Abutment***3.4mm(D) X 2mm(H)***Abutment:; Pillar; Abutment; Abutment; Pilastro; Pillar***CE dose***Use by 2016-09***Sterile using Radiation***RX Only***Do not reuse***Consult accompanying documents***Do not re-sterilize***Do not use if package is damaged***ILPAC3217***2011091179***"P-LBLNY3P***Rev. D***". Intended to provide a means to attach crown restorations or implant frameworks to implants.
- Recall number
- Z-1456-2012
- Recalling firm
- Biomet 3i, LLC
- Product
- Certain Low-Profile, Angled Abutment, Model Number ILPAC3217. Product is labeled in part: "***Biomet 3i***4555 Riverside Drive , Palm Beach Gardens, FL 33410 USA***REF ILPAC3217***LOT 2011091179***Certain Low Profile 17 Abutment***3.4mm(D) X 2mm(H)***Abutment:; Pillar; Abutment; Abutment; Pilastro; Pillar***CE dose***Use by 2016-09***Sterile using Radiation***RX Only***Do not reuse***Consult accompanying documents***Do not re-sterilize***Do not use if package is damaged***ILPAC3217***2011091179***"P-LBLNY3P***Rev. D***". Intended to provide a means to attach crown restorations or implant frameworks to implants.
- Status
- Terminated
- Initiated
- 2012-01-10
- Posted
- 2012-04-25
- Terminated
- 2012-04-30
- Reason
- Biomet 3i initiated a recall for a small percentage of the 33mm (ILPAC3217) abutment packages that may contain the 5mm (ILPAC5217) abutment.
- Root cause
- Material/Component Contamination
- Action
- Biomet 3i , LLC sent Urgent: Medical Device Recall notices on 1/10/2012 to each customer in via e-mail, facsimile, telephone or postal mail. The letters identified the affected product and the reason for the recall. Each customer was instructed to check their respective inventory for the affected product and return any unused product to Biomet 3i at the address provided. Biomet 3i will issue replacement product at no charge. Questions or concerns should be directed to 1-800-342-5454.
- Quantity
- 400
- Distribution
- Worldwide Distribution -- Canada, Chile, Columbia, France, Germany, Hong Kong, India, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, Singapore, South Africa, Spain, Sweden, Switzerland, UK, US, and Vietnam.
- Lot, serial or model codes
- Lot Numbers: 2011060659, 2011070773, 2011070988, 2011071332, 2011071575, 2011080241, 2011080697, and 2011091179.
- 510(k) numbers
- ["K092341"]
- PMA numbers
- not on file
- Product code
- NHA
- Firm FEI
- 1038806
- Firm city
- Palm Beach Gardens
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28